Application 021001

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AXERT	ALMOTRIPTAN MALATE	TABLET;ORAL	EQ 6.25MG BASE	Yes	No
002	AXERT	ALMOTRIPTAN MALATE	TABLET;ORAL	EQ 12.5MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021001-001	AXERT	ALMOTRIPTAN MALATE	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2001-05-07
N021001-002	AXERT	ALMOTRIPTAN MALATE	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2001-05-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021001-001	AXERT	EQ 6.25MG BASE	TABLET / ORAL	RLD	2001-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021001-002	AXERT	EQ 12.5MG BASE	TABLET / ORAL	RLD	2001-05-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021001-001	AXERT	EQ 6.25MG BASE	TABLET / ORAL	RLD	2001-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021001-002	AXERT	EQ 12.5MG BASE	TABLET / ORAL	RLD	2001-05-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021001-001	AXERT	EQ 6.25MG BASE	TABLET / ORAL	RLD	2001-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021001-002	AXERT	EQ 12.5MG BASE	TABLET / ORAL	RLD	2001-05-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2001-05-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021001-001	AXERT	EQ 6.25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021001-002	AXERT	EQ 12.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	2001-05-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N021001-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021001-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021001-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021001-002	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Almotriptan Malate	ALMOTRIPTAN MALATE	Teva Pharmaceuticals USA, Inc.	c41a4579-9db0-402b-81b1-0adf5b3978c3	2017-05-31	Warnings, Adverse reactions	Name fallback generic name: ALMOTRIPTAN MALATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-210	AXERT	almotriptan malate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-210	AXERT	almotriptan malate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-210	AXERT	almotriptan malate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-211	AXERT	almotriptan malate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-211	AXERT	almotriptan malate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-211	AXERT	almotriptan malate	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48399	SUPPL	2017-05-17
48385	SUPPL	2017-05-17
4005	SUPPL	2014-08-11
35850	SUPPL	2014-08-08
35849	SUPPL	2009-05-11
14139	SUPPL	2009-05-11
4004	SUPPL	2009-05-06
35848	SUPPL	2009-04-03
14138	SUPPL	2009-04-03
26451	SUPPL	2009-04-01
4003	SUPPL	2009-04-01
51214	SUPPL	2005-02-01
26450	SUPPL	2004-06-07
41869	ORIG	2004-04-15
23617	ORIG	2003-12-08
51213	SUPPL	2001-10-05
26449	ORIG	2001-05-07
14137	ORIG	2001-05-07
63849	ORIG	1900-01-01
63848	ORIG	1900-01-01
58101	ORIG	1900-01-01
53170	ORIG	1900-01-01
53169	ORIG	1900-01-01